ISO handbook
ISO 9001:2015 for Small Enterprises

- What to do ? Advice from ISO/TC 176

The 4th edition of this ISO handbook was produced to give guidance to small organizations on developing and implementing a quality management system, based on the International Standard ISO 9001:2015, Quality management systems - Requirements. All the requirements of ISO 9001 are generic and are intended to be applicable to all organizations, regardless of their type, size, or the products and services they provide.

It is not expected that you will sit down and read this handbook in one sitting. It is broken up into the following sections to be read and used separately and referred to as the need arises.

Quality Management System

This section gives an overview of what an ISO 9001 quality management system is.

How to Start

This gives some practical advice on different options, should you wish to introduce a quality management system into your organization or update an existing one.

Guidance on
ISO 9001

This is the major part of the handbook and includes the text of ISO 9001 itself. It provides guidance to help understand the requirements, together with examples and suggestions of how these requirements could be met.

Annex A

This Annex gives a method of implementing ISO 9001 in a small enterprise.

Annex B

This Annex gives a brief outline of a certification/ registration process.

Annex C

This Annex (taken from ISO 9000) lists the seven quality management principles which provided the basis for the ISO 9001.

Bibliography

The Bibliography gives details of standards that are referenced in ISO 9001, and other references that are used in this handbook or which might be useful.

This handbook does not set any requirements, nor add to or otherwise change the requirements of ISO 9001, and is simply intended to be helpful.

Most organizations face challenges when developing a quality management system. In a small organization these challenges are potentially greater due to:

minimal available resources;

costs involved in setting up and maintaining a quality management system;

difficulty in understanding and applying the standard, especially some of its concepts such as organizational context, organizational knowledge, process approach and risk based thinking.

For the purposes of this handbook, a small organization is not only a matter of the number of employees or size, but also the way it is managed. With only a few people involved, communications in a small organization can often be simple and more direct. Individuals are expected to undertake a wide variety of tasks within the organization. Decision making is confined to a few people (or even one).

Much of the advice given in this handbook will also be relevant to medium and large organizations, which are often good at adapting techniques and improvements developed successfully elsewhere. However, caution should be exercised, since the features on which the advice is based might not always be appropriate in medium and large organizations.

For you, the small organization’s manager, the time and money spent implementing a quality management system should be looked at in the same way as any other investment you make. For it to be viable, you have to be able to achieve a return for your time and effort, through improvements in your organization’s processes and marketability of your products and services. Your decisions at the early stages of introducing/developing your quality management system will have a major influence in these areas.

It is possible to implement a quality management system in conformity to ISO 9001 without seeking third party registration or certification.

Any small organization that chooses to develop its quality management system beyond the ISO 9001 requirements should consider using ISO 9004:2009, Managing for the sustained success of an organization — A quality management approach.

This handbook has been written by a task group of technical experts from ISO’s Technical committee TC 176 which is responsible for the ISO 9000 family of standards. A draft was circulated to all the member national standards bodies and liaison organizations of ISO/TC 176 to obtain feedback and comments; these will have been considered by the task group prior to release of the final text.